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TFT Halls & Rooms

Nov 06, 2013 9:00 AM - Nov 08, 2013 6:00 PM

TFT Building, 3-6-11 Ariake, , Koto-ku,, Tokyo, 135-8071 Japan

10th Annual Meeting DIA Japan 2013

Session 4 / Venue 1: The Future of ICH ~ (English Language Only)

Session Chair(s)

Akira  Kawahara, PhD, MPharm, RPh

Akira Kawahara, PhD, MPharm, RPh

(JPMA), Japan

Nobumasa  Nakashima

Nobumasa Nakashima

Health Policy Director, National Healthcare Policy Secretariat

Cabinet Office, Japan

Through its 20 years’ activities, ICH finalized more than 70 guidelines, and many countries other than Japan, the US and Europe are getting to make use of those guidelines. In addition, activities of ICH have been increasing its importance increasingly in the world where science and technology is progressing remarkably and development, supply and sales of medicinal products are globalizing. Taking into account such circumstances, ICH members discuss subjects such as the governance of ICH including its membership, new topics to be considered at ICH to revitalize activities, maintaining transparency, and promoting globalization of ICH activities. In this session, representatives from Japanese, US and European regulatory agencies and from ICH industry will give presentations on the current and future activities of ICH and international cooperation from their points of view, and discuss the future shape of ICH. Discussion time is held at the end of the session.

Speaker(s)

Naoyuki  Yasuda, MSc

Future Activity of ICH from MHLW/PMDA’s Point of View

Naoyuki Yasuda, MSc

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Associate Executive Director , Office of International Programs

Theresa  Mullin, PhD

Future Activity of ICH From the FDA Point of View

Theresa Mullin, PhD

FDA, United States

Associate Center Director - Strategic Initiatives, CDER

Emer  Cooke, MBA, MSc

Future Activity of ICH from the EU Point of View

Emer Cooke, MBA, MSc

The European Medicines Agency, Netherlands

Executive Director, Chair, ICMRA

Peter  Honig, MD, MPH, FACP

The Future of ICH – Industry Perspective

Peter Honig, MD, MPH, FACP

Advisor and Board Member, United States

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